CREO 6120.2010Recalls & reported problems
Globus Medical, Inc. · Geared Reducer, Overhead, Threaded · Class 1
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095173376), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 death.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- Multiple Organ Dysfunction Syndrome1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 6, 2026Device-Device Incompatibility
T WAS REPORTED THAT THESE PARTS WOULD ENGAGE WITH TULIP, BUT THE SET SCREW WOULD NOT THREAD INTO THE TULIP. WHEN THE REDUCERS WERE ON THE TULIP & FULLY REDUCED ROD. THIS ADDED AN EXTRA 45 MIN TO SURGERY AS THEY TROUBLESHOOTED THE ISSUES, ULTIMATELY RESOLVED BY SWITCHING TO NEW INSTRUMENTATION. THE PATIENT PASSED AWAY AT THE HOSPITAL 5 DAYS LATER, THE SURGEON BELIEVES THE PATIENT HAD PROPOSAL INFUSION SYNDROME.
Patient problems: Multiple Organ Dysfunction Syndrome
MAUDE report 23975742 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page